Grant: Op Gr: COVID-19 Rapid Research FO - Clinical Mgmt/Health System Interventions

COVID-19 is a global pandemic that has taken a heavy toll on Canada. The prevention of new cases is critical, but vaccines are not likely to be ready for study for 1+ years. CORIPREV-LR is a randomized controlled trial of a prevention strategy called post-exposure prophylaxis (PEP) against COVID-19, in high-risk exposed contacts of confirmed cases. PEP is a well-established approach to the prevention of infectious diseases, in which people who were recently exposed to the virus take a short course of medication to prevent infection. Our primary objective is to find out whether taking an oral medication called lopinavir/ritonavir (LPV/r) for 14 days as PEP protects people from getting COVID-19, if taken shortly after they are exposed to a confirmed case. We will use an innovative 'ring'-based study design, in which we define a 'ring' of exposed contacts around confirmed COVID-19 cases, and then randomize these rings to either the study drug or control (no study drug) condition. This ring design was a key part of the successful eradication of smallpox, and the evaluation of a vaccine used for Ebola. The study drug LPV/r is an anti-HIV medication already marketed in Canada as KaletraTM. Molecular, animal model and early clinical data suggest it to have antiviral activity against SARS-CoV-2, the virus that causes COVID-19. It has a well-established safety profile, based on extensive global experience using it for HIV treatment and prevention for over 20 years. If our trial shows it to be effective, it could be immediately put to use in Canada and around the world, constituting a breakthrough in pandemic control. Our study team includes Canadian experts on the frontlines of SARS, MERS, H1N1, Ebola, and HIV, are our connections with clinical trial networks both in Canada and internationally will allow rapid data-sharing and dissemination of results.